El-Banayosy A, Arusoglu L, Kizner L, Tenderich G, Minami K, Inoue K, Körfer R
Department of Thoracic and Cardiovascular Surgery, Heart Center North Rhine-Westphalia, Ruhr University of Bochum, Bad Oeynhausen, Germany.
J Thorac Cardiovasc Surg. 2000 Mar;119(3):581-7. doi: 10.1016/s0022-5223(00)70140-1.
Long-term mechanical circulatory support as a bridge-to-transplantation procedure and bridge to recovery is of increasing importance. The implantable left ventricular assist devices, Novacor N100 left ventricular assist system (Baxter Healthcare Corporation, Berkeley, Calif) and TCI HeartMate vented electric left ventricular assist system (Thermo Cardiosystems Inc, Woburn, Mass), have proved to be efficient devices in bridge-to-transplantation settings and for prolonged support. The two systems were compared with regard to reliability and morbidity.
Between October 1996 and March 1998, a prospective, single-center study was done that included 40 patients, 20 of whom were treated with the Novacor system and 20 of whom were treated with the HeartMate device. The diseases were mainly dilated cardiomyopathy (13/9) and ischemic cardiomyopathy (6/10). There were no statistically significant differences between the two groups regarding age, sex, preoperative clinical blood chemistry values, hemodynamic data, or risk factors.
There were no statistically significant differences between the two groups with regard to postoperative hemodynamics, organ recovery, out-of-hospital support, and survival to heart transplantation. Mean duration of support was 235.3 +/- 210 days for the Novacor group and 174.6 +/- 175 days for the HeartMate group and mean out-of-hospital support was 241 +/- 179 days and 166 +/- 152 days for the two groups, respectively. Neurologic complications occurred significantly more often among the Novacor group, whereas the HeartMate group had a higher prevalence of infections and technical problems, which was statistically significant. Survival to transplantation was 65% for the Novacor group and 60% for the HeartMate group.
Most patients had organ recovery with left ventricular assist system support, and a considerable number of patients in both groups underwent transplantation. However, both devices need revision to address the current problems, that is, thromboembolism for the Novacor device and infection and reliability for the HeartMate device.
长期机械循环支持作为桥接移植手术和恢复的手段，其重要性日益增加。可植入式左心室辅助装置，即诺华珂N100左心室辅助系统（百特医疗保健公司，加利福尼亚州伯克利）和TCI HeartMate透气电动左心室辅助系统（热控心血管系统公司，马萨诸塞州沃本），已被证明在桥接移植情况下以及长期支持中是有效的装置。对这两种系统的可靠性和发病率进行了比较。
在1996年10月至1998年3月期间，进行了一项前瞻性单中心研究，纳入40例患者，其中20例接受诺华珂系统治疗，20例接受HeartMate装置治疗。疾病主要为扩张型心肌病（13/9）和缺血性心肌病（6/10）。两组在年龄、性别、术前临床血液化学值、血流动力学数据或危险因素方面无统计学显著差异。
两组在术后血流动力学、器官恢复、院外支持和心脏移植生存率方面无统计学显著差异。诺华珂组的平均支持时间为235.3±210天，HeartMate组为174.6±175天，两组的平均院外支持时间分别为241±179天和166±152天。诺华珂组神经并发症的发生率明显更高，而HeartMate组感染和技术问题的发生率更高，具有统计学意义。诺华珂组移植生存率为65%，HeartMate组为60%。
大多数患者在左心室辅助系统支持下器官得到恢复，两组中相当数量的患者接受了移植。然而，两种装置都需要改进以解决当前的问题，即诺华珂装置的血栓栓塞问题以及HeartMate装置的感染和可靠性问题。
